POST-MORTEM EXAMINATIONS: Yes - Sacrifice on gestation day 29 - Organs examined: all does were subjected to Caesaren section under surgical anesthesia.

Ovaries and uterine content:

The ovaries and uterine content was examined after termination: YesExaminations included:- Gravid uterus weight: No data- Number of corpora lutea: Yes - Number of implantations: Yes - Number of resorptions: Yes - Number and sex of live and dead fetuses: Yes

Fetal examinations:

External examinations: Yes - Body weights of the live pups were recoded.- All fetuses underwent a detailed gross examination for the presence of external congenital abnormalities.

Soft tissue examinations: Yes - The live fetuses of each litter were then placed in an incubator for 24 hours for evaluation of neonatal survival. - All surviving pups were sacrificed, and all pups examined for visceral abnormalities (by dissection).

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:- The pregnancy rates was comparable among groups and survival of pregnant females was not affected by treatment with sodium metabisulphite.- Maternal body weights and weight gains were comparable among groups.- There were no treatment-related effects on the number of abortions, corpora lutea, implantation sites, live litters and resorptions.

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:- The number of live and dead fetuses, sex ratio and average fetal weight was not affected by treatment of dams with sodium metabisulphite.- The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

> 123 mg/kg bw/day

Based on:

test mat.

Basis for effect level:

other: teratogenicity

Remarks on result:

not determinable

Remarks:

no NOAEL identified

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The administration of up to 123 mg/kg bw/d of sodium metabisulphite to pregnant rabbits for 13 consecutive days had no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. Thus, the NOAEL for maternal and developmental toxicity can be expected above the highest dose of 123 mg/kg body weight sodium metabisulphite in this rabbit study.

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